FDA released a new report on Nov. 21 that suggests increased oversight has led to tangible improvements in quality compliance across the medical device industry over the past decade.
Since 2007, FDA has increased its annual number of medical device inspections by 46% and has increased annual inspections of foreign firms by 243%. In that timeframe, the agency also helped establish the Medical Device Single Audit Program, which has increased its oversight of foreign manufacturing facilities beyond the inspections the agency performs on its own. The question is, have these actions translated into improved quality compliance?
The short answer, according to a new report issued by FDA's Center for Devices and Radiological Health (CDRH), is yes. According to the Medical Device Enforcement and Quality Report, FDA's focus on identifying reporting deficiencies during inspections has led to an increase in voluntary recalls and adverse event reporting. Even better, the report suggests that most firms (82% between 2008 and 2017) have corrected violations on follow-up inspections. The agency attributes this improvement to a more interactive approach regarding observed violations.
“As medical device manufacturing has become an increasingly global enterprise, the FDA has taken forceful action to increase inspections of medical device firms, especially those located in foreign countries. Over the past decade, we’ve increased the annual number of international device inspections by 243% taking into account that quality system issues are more likely to occur in firms located overseas,” said Jeffrey Shuren, MD, director of the CDRH. “Our increased oversight has led to tangible results with improved compliance."
FDA said it has also taken steps to promote device quality, not just compliance, with regulations through the Case for Quality initiative that includes a voluntary quality maturity appraisal pilot launched this year. MD+DI previously reported on that pilot program here.
The agency said it has also taken more of a risk-based approach in the past decade to address specific device areas of concern. The new report, published Nov. 21, includes a case study on infusion pumps that are designed to deliver fluids into a patient's body in controlled amounts. These devices can deliver nutrients or medications, such as insulin, antibiotics, chemotherapy drugs, and pain relievers. From 2005 through 2009, FDA received roughly 56,000 reports of adverse events associated with the use of infusion pumps, including numerous injuries and death. This led to the agency's Infusion Pump Improvement Initiative in 2010.
According to the new report, FDA enforcement activity led to an initial three-fold increase in voluntary recalls from affected firms – like this 2014 Hospira recall – as the agency worked with companies to address identified device design and manufacturing deficiencies. The report notes a 56% reduction in annual recalls related to these devices since 2014 and an 82% reduction in annual medical device reports since 2015.
Another case study included in the report focus on automated external defibrillators (AEDs), which have been the subject of a lot of FDA action in recent years, such as when Philips was forced to stop making AEDs until certain manufacturing problems were fixed. According to the agency's report, there has been a 70% reduction in annual recalls and a 27% reduction in the number of medical device reports related to these devices since 2010 as a result of increased FDA enforcement activity.
Radiation therapy devices also earned a spot in the recent report due to FDA's 2010 efforts to reduce unnecessary radiation exposure from medical imaging, as well as the agency's identification that there was a recurring issue of accidental radiation therapy overexposure due to device software failures. Since 2011, there has been an 80% reduction in annual recalls related to these devices, the report notes.
The full nine-page report is available here.